Kornimate/medical-research-clean huggingface dataset:
elucidate: enabling lung cancer identification using folate receptor targeting

Conditions: Lung Neoplasms; Lung Cancer

Summary: this is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per ct/pet/mri or other imaging based on standard of care. this study aims to assess the efficacy of otl38 and near infrared imaging (nir) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of otl38.


Eligibility criteria:
inclusion criteria: 1. male and female subjects 18 years of age and older 2. have a primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on ct/pet or other imaging 3. are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed by anatomic lung resection 4. female subjects of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion 5. ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments exclusion criteria: 1. previous exposure to otl38 2. any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject 3. history of anaphylactic reactions to folate, including synthetic folic acid (pteroylmonoglutamic acid) and contrast agents containing indocyanine green for near infrared imaging. subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation. 4. history of allergy to any of the components of otl38, including folic acid 5. a positive serum pregnancy test at screening or a positive urine pregnancy test on the day of surgery or day of admission for female subjects of childbearing potential 6. clinically significant abnormalities on electrocardiogram (ecg) at screening. 7. presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule 8. impaired renal function defined as egfr\< 50 ml/min/1.73m2 9. impaired liver function defined as values \> 3x the upper limit of normal (uln) for alanine aminotransferase (alt) or aspartate aminotransferase (ast), alkaline phosphatase (alp), or \>2x uln for total bilirubin except in subjects with gilbert's syndrome. 10. received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug 11. known sensitivity to fluorescent light

Keywords: intraoperative imaging
unbound bilirubin levels in healthy term and late preterm infants

Conditions: Neonatal Jaundice

Summary: specific aim 1: to determine total serum bilirubin (tsb) and unbound bilirubin (bf) levels in term and late preterm infants during the first week of life. specific aim 2: measure bf levels in breast fed and formula fed infants and examine their relationship to unbound fatty acid (ffau) levels. specific aim 3: to demonstrate that phototherapy results in different changes in tsb and bf.


Eligibility criteria:
inclusion criteria: * term and late-preterm infants admitted to the regular care nursery of robert wood johnson university hospital will be eligible for the study exclusion criteria: * infants suffering from genetic, chromosomal or surgical conditions will be excluded.
demonstration of a next generation pet ct system

Conditions: Oncology

Summary: the intent of this evaluation is to obtain user feedback on device performance, user preference, image quality, workflow, and new device features, a necessary part of product development. this study will also help to inform protocol development in reducing both scan time and/or radiologic tracer dose. the goal of this study is to collect a library of image data from the hybrid pet/ct system to be used for evaluation and optimization of the image quality of the system in a clinical setting and as comparison with the standard of care hybrid pet/ct system, discovery mi 25m (dmi5r).


Eligibility criteria:
inclusion criteria: 1. adult, who is at least 18 years of age; 2. a clinical indication for pet/ct examination according to current clinical practice standards; 3. able and willing to provide informed consent for participation in this study exclusion criteria: 1. diabetic patient with a glucose level ≥ 150 mg/dl at the time of the exam (for fdg) or, 2. known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age. no study specific pregnancy test will be performed for this study); or, 3. previously enrolled in this study.
extent of surgical trauma in open and laparoscopic cholecystectomy

Conditions: Chronic Calculous Cholecystitis

Summary: the aim of this work is to evaluate which of the two types of operation (traditional/open and laparoscopic) has more impact on patients who were operated electively due to their chronic calculous cholecystitis.

the prospective, single center, randomized study includes 120 patients who are operated electively - 60 patients operated laparoscopically and 60 patients operated traditionally. biohumoral and endocrine parameters of response to trauma are determined from 24 hour urine and blood: adrenalin, noradrenalin, metabolites of corticosteroid hormone - 17- hydroxyl and 17- keto steroid (hplc method), c reactive protein and albumin, glycemia, creatine phosphokinase, lactate dehydrogenase, sedimentation of erythrocytes and serum concentration of potassium.

Eligibility criteria:
inclusion criteria: * chronic calculous cholecystitis exclusion criteria: * previous biliary surgery * cholangitis * obstructive jaundice

Keywords: cholecystectomy cholecystitis laparoscopy cholelithiasis operative trauma
predictors of reactive thrombocytosis in critically ill septic patients

Conditions: Sepsis; Thrombocytosis; Critically Ill

Summary: reactive or secondary thrombocytosis is defined as abnormally high platelet count (≥4,50,000 platelets per micro-liter) in the absence of chronic myeloproliferative disease. in critically ill patients reactive thrombocytosis is not uncommon during recovery phase and an association has been seen with poor outcome and increased risk of subsequent vte. however, not all patients with infection respond with thrombocytosis. no study has enumerated the risk factors or predictors of reactive thrombocytosis in critically ill septic patients.

all patients admitted to intensive care unit of the department of critical care medicine during one year period will be screened for possible inclusion in this study. in this prospective observational study, demographic and clinical characteristics of all icu patients who fulfill inclusion criteria will be collected along with relevant laboratory tests done for patient management routinely. icu prognostication scores, i.e., acute physiologic and chronic health evaluation (apache) ii score and sequential organ failure assessment (sofa) score will also be recorded. icu survivors will be followed up in their routine icu follow up clinic visits. sample size was estimated at 10% incidence rate of reactive thrombocytes, two sided 95% confidence interval and 4.5% margin of error of the incidence rate, sample size came out to be 171. finally in this study investigators have targeted to include at least 180 participants. sample size was estimated using software power analysis and sample size, 2008 (pass-8).

Eligibility criteria:
inclusion criteria: * all adult (≥18 years) icu patients with the diagnosis of sepsis will be considered. exclusion criteria: * age \<18 years * pregnancy * h/o malignancy * thrombocytosis at admission * primary thrombocytosis * post-splenectomy * chronic inflammatory disease (e.g. connective tissue disorders, ibd, temporal arteritis) * known immunosupressive condition * chronic infectious diseases (e.g. tuberculosis, chronic pneumonitis)
artificial intelligence in diagnosis of dfna9

Conditions: DFNA9; Sensorineural Hearing Loss

Summary: to study the positive predictive value of audiogene v.4.0 open source online machine learning tool in accurately predicting dfna9 (deafness autosomal dominant ninth) as top 3 gene loci in a large series of genetically confirmed c.151c\>t,p.pro51ser (p.p51s) variant carriers in coch (coagulation factor c homology).

dfna9 is an autosomal dominant hereditary adult-onset and progressive sensorineural hearing loss which is associated wit vestibular deterioration. today, artificial intelligence plays an increasing role in diagnosis of mendelian hearing losses and in fitting of cochlear implants. an application of this kind is the open source program, audiogene v4.0, which was elaborated by the center for bioinformatics and computational biology, university of iowa city, iowa, usa. the shape of the audiogram (audioprofile) is easily recognizable in many autosomal dominantly inherited hearing losses. machine learning based software tools, such as audiogene v4.0, which was originally developed for prioritizing loci for the sanger sequencing, could help the clinicians in early diagnosis of dfna9. this tool only need subjects' age and hearing thresholds (decibel hearing loss (db hl)) at frequency range of 0.125 - 8 khz (kiloherz), left, right or binaural average in order to predict top 3 gene loci according to the data entered in the program. goal: to use auditory data of a large series of genetically confirmed p.p51s variant carriers causing dfna9, which were previously collected for the genotype-phenotype correlation study which terminated recently. all individual left and right sided hearing thresholds (ranging from 0.125 to 8khz, with the exception of 1.5 khz) as well as binaural averaged thresholds were run through audiogene v4.0. descriptive statistics were assessed and statistical analysis was carried out to check for possible differences between age or hearing thresholds between the carrier group with accurate prediction against the carrier group with inaccurate prediction.

Eligibility criteria:
inclusion criteria: * at least 18 years * genetically confirmed c.151 c\>t, p.pro51ser variant carrier in coch gene * not contra-indication for audiometric testing exclusion criteria: * \<18 years * no carrier status for c.151c\>t, p.pro51ser * no auditory data available

Keywords: coch dfna9 sensorineural hearing loss
simple changes weight loss intervention

Conditions: Overweight

Summary: the investigators examined feasibility and acceptability of a non-restrictive diet focused on increasing dietary fiber and lean protein for weight loss. fifteen obese adults enrolled in a 12-week assessment which included 6 bi-weekly individual dietary counseling sessions to attain a daily goal of higher fiber (\>35 g/day) and lean protein (0.8 g per kilogram/day of individual's ideal body weight).

participants were instructed to increase both their dietary fiber intake to 35 g/day and protein intake to 0.8 g per kilogram/day of their ideal body weight. loss of 5% of their body weight are considered to achieve the weight-loss goal. the intervention included 6 bi-weekly, 30-minute individual dietary counseling sessions over 12-weeks. behavioral strategies including self-monitoring, problem solving, goal setting, stimulus control, food substitution, and relapse prevention were taught to assist participants in meeting their fiber and protein goals.

Eligibility criteria:
inclusion criteria: 1. interested in losing weight and have a body mass index (bmi) 30-45 kg/m2; 2. ages 21 to 70; 3. able to provide informed consent; 4. physician's approval of his/her patients to participate; 5. non-smoker (given nicotine's effect on weight suppression, on hdl, and smoking cessation's effect on weight exclusion criteria: 1. clinically diagnosed diabetes, or an hba1c ≥ 6.5%; 2. an acute coronary event within the previous 6 months; 3. pregnant or lactating; 4. plans to move out of the area within the 12-week study period; 5. diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g., inflammatory bowel disease, active diverticulitis, renal disease); 6. following a low-carbohydrate, high-fat dietary regimen such as the atkins' diet or participating in a weight loss program; 7. previously had bariatric surgery; 8. currently using weight loss medication; 9. diagnosis of an eating disorder (anorexia nervosa, bulimia nervosa or binge eating); 10. unable to provide consent.

Keywords: fiber lean protein loss weight
platinum rechallenge in patients with platinum-sensitive mtnbc

Conditions: Metastatic Breast Cancer

Summary: platinum retreated in patients with platinum sensitive mtnbc

platinum retreated in second- or third-line patients with platinum sensitive metastatic triple negative breast cancer (randomised, phase ii, npn trial)

Eligibility criteria:
inclusion criteria: 1. females with age between 18 and 70 years old 2. performance status no more than 2 3. life expectancy longer than 3 months 4. histological proven unresectable recurrent or advanced breast cancer 5. triple-negative for estrogen receptor (er), progestogen receptor (pr), and human epithelial receptor-2 (her2) by immunohistochemistry (er \<1%, pr \<1% and her2 negative). a negative her2 gene amplification should be verified by fish test for those patients with her2 (2+). 6. patients must have progressed after 1or 2 prior chemotherapy regimens for metastatic disease, cis/carbo-platin pretreated only 1 previous line prior to randomisation. platinum sensitive in this study is defined as complete or partial or stable disease following completion (a minimum of 4 treatment cycles) of previous platinum-based chemotherapy and disease progression greater than 3 months after completion of their last dose of platinum chemotherapy (last dose). 7. at least one measurable disease according to the response evaluation criteria in solid tumor (recist 1.1) 8. radiation therapy within 4 weeks prior to enrollment 9. all patients enrolled are required to have adequate hematologic, hepatic, and renal function 10. be able to understand the study procedures and sign informed consent. exclusion criteria: 1. patients had prior treatment with vinorelbine 2. pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study 3. patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. radiotherapy should be completed within 4 weeks prior to the registration 4. treatment with an investigational product within 4 weeks before the first treatment 5. severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction 6. uncontrolled serious infection 7. other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
a prospective, multi-center, randomized controlled blinded trial demonstrating the safety and effectiveness of vns therapy® system as adjunctive therapy versus a no stimulation control in subjects with treatment-resistant depression

Conditions: Treatment Resistant Depression

Summary: objectives of this study are to determine whether active vns therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

a prospective, multi-center, randomized, controlled, blinded trial of subjects implanted with vns therapy. active treatment and no stimulation control are randomized, at least two weeks after implantation and observed for 12-months. after completing the 12 month endpoint in the rct portion of the study, all recover subjects will transition into the prospective, open-label, longitudinal portion of the study. subjects in the control arm of recover will be activated after completing the 12 month endpoint. after completion of enrollment in the rct portion or meeting of interim success criterion (whichever comes first), up to 5,800 new subjects may enroll directly into the open-label,prospective, longitudinal study. these subjects will participate in the study for approximately 5 years. the study has been designed in accordance with the centers for medicare and medicaid services coverage with evidence development (ced) decision entitled "decision memo for vagus nerve stimulation (vns) for treatment resistant depression (trd) (cag-00313r2).

Eligibility criteria:
inclusion criteria: the patient must be in a major depressive disorder (mdd) episode for ≥ two years or have had at least four episodes of mdd, including the current episode. the patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose. the patient is experiencing a major depressive episode (mde) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the vns device. patients must maintain a stable medication regimen for at least four weeks before device implantation. exclusion criteria: current or lifetime history of psychotic features in any mde; current or lifetime history of schizophrenia or schizoaffective disorder; current or lifetime history of any other psychotic disorder; current or lifetime history of rapid cycling bipolar disorder; current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder; current suicidal intent; or treatment with another investigational device or investigational drugs.

Keywords: vns depression trd
trial of tri-weekly tj versus weekly tj for stage ii-iv mullerian carcinoma

Conditions: Epithelial Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Summary: the purpose of the study is to compare progression-free survival of conventional paclitaxel and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage ii-iv ovarian epithelial, primary peritoneal, or fallopian tube cancer.

this is a randomized, multicenter study. patients are stratified according to residual disease 1 cm or less vs more than 1cm, stage ii vs iii vs iv, and histology (clear cell or mucinous vs. serous or others). patients are randomized to one of two treatment arms. arm i: patients receive paclitaxel iv over 3 hours and carboplatin iv over 60 minutes on day 1 for 6-9 cycles. arm ii: patients receive paclitaxel iv over 1 hour days 1, 8, and 15 and carboplatin iv over 60 minutes on day 1 for 6-9 cycles. in both arms, cycles repeat 6 cycles every 21 days in the absence of disease progression or unacceptable toxicity. additional 3 cycles are given if clinical partial or complete response after 6 cycles. projected accrual: a total 600 patients (300 per treatment arm) will be accrued for this study within 3 years. assuming median progression-free survivals of 16 months and 21 months and a recruitment period of 3 years this can be achieved by recruiting 600 patients designed to have 80 % detect to a difference between the two arms at the two-sided 5% level of statistical significance.

Eligibility criteria:
inclusion criteria: * histologically confirmed stage ii-iv ovarian epithelial, primary peritoneal, or fallopian tube cancer * no prior chemotherapy * age: 20 and more * performance status: ecog 0-3 * 1) absolute neutrophil count at least 1,500/mm3 2) platelet count at least 100,000/mm3 3) bilirubin less than 1.5mg/dl 4) sgot less than 100 iu/l 5) serum creatinine less than 1.5mg/dl * written informed consent exclusion criteria: * patients with ovarian borderline tumor * patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer that is curable with local therapy * patients with active infection or uncontrolled diabetes * patients with unstable angina, or those who have had a myocardial infarction within the past 6 months, or patients with serious arrythmia that requires medication * patients who have a history of hypersensitivity to polyoxyethylated castor oil (cremophor el)

Keywords: ovarian neoplasms randomized controlled trial paclitaxel carboplatin
ilt-101 in patients with active moderate to severe systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the efficacy and safety of ilt-101 (human recombinant interleukin 2 (il-2)) in patients with moderate to severe systemic lupus erythematosus.

interleukin 2 (il-2) plays an important role on immune homeostasis by acting on t lymphocytes. in systemic lupus erythematosus, there is a so called "insufficiency" in a subpopulation of t lymphocytes, the regulatory t cells (tregs) leading to altered immune balance between regulatory and effector t cells. these cells seem to play a major role in the physiopathology of the disease. many researches enlighten the fact that this tregs/teffs balance can be restored by administering low dose of il-2. it is thus assumed that treatment with low dose of il-2 may impact positively the progression of the disease and thus help patients improving their clinical outcomes.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of sle * active sle * on stable background therapy for 1 month * using highly effective contraception exclusion criteria: * serious organ failure (renal functional impairment, severe central nervous system manifestations, severe heart failure, liver failure) * any clinical evidence of active chronic infection hiv, hepatitis b, hepatitis c * clinical significant pleuritis or pericarditis * type1 diabetes and/or crohn's disease * use of benlysta (belimumab) in the past 4 weeks * use of rituximab in the past 6 months * vaccination with live attenuated virus in the last month
gene expression profile of breast cancer samples after vitamin d supplementation

Conditions: Breast Neoplasms; Postmenopausal Disorder

Summary: the purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor cell proliferation and influence gene expression profile of breast cancer samples from post-menopausal patients.

women affected by breast cancer present lower 1,25(oh)2d3 or 25(oh)d3 serum levels than unaffected ones. calcitriol supplementation may be indicated to post-menopausal women to reduce bone loss. vitamin d has antiproliferative effects in breast cancer cell lines and breast cancer xenografts. post-menopausal breast cancer patients will be prescribed calcitriol supplementation, in doses indicated to prevent osteoporosis, while they are submitted to biopsy, staging exams and have their breast surgery scheduled (approximately one month). tumor dimension and proliferation rate (as determined by ki67 expression), 25(oh)d3 and/or 1,25(oh)2d3 serum concentration, will be evaluated before and after calcitriol supplementation. tumor gene expression will be evaluated in samples collected before and after supplementation to analyze the differential profile.

Eligibility criteria:
inclusion criteria: * postmenopausal women * invasive breast carcinoma * clinical conditions for breast surgery * no previous neoadjuvant treatment for breast cancer * agreement to take part in the study and sign the informed consent exclusion criteria: * history of hypercalcemia or nephrolithiasis * current use of corticosteroids, vitamin d supplementation, hrt * previous chemotherapy, hormonotherapy or radiotherapy * parathyroid disease * absence of clinical condition to receive supplementation

Keywords: breast neoplasms calcitriol postmenopausal cell proliferation gene expression profiling